If you are a Regulatory Affairs Professional, you really need to listen to this. Samantha Alsbury from TOPRA is providing us with her advice on how to be a great professional. Thanks again to Samantha for her time and for the valuable information she had shared with us.
One of the challenge I have felt in my experience while working in medical devices is also to know about human autonomy. This adds to the complexity because sometimes to understand the device from a design perspective it is necessary to know why design inputs work the way they do. For that a preliminary knowledge of human anatomy is needed. Especially if you have interest towards clinical or medical affairs role.
The solution to this is Team Work. You should not think you are alone. You should ask Marketing or sales service to explain to you. Or if you can meet a surgeon that works with a device could be great. Be curious but don‘t work alone. Autonomy is also the act of collaboration and self-education.
Hi Dr Mira. Not really an easy move as the regulations are completely different. But this will be easier than to start from scratch with no regulatory background
What advice, would you have for a person, who does not have an engineering or life science degree. I have a law degree and want to get into, Regulatory Affairs of Medical Devices, I also 15 years experience of production of Medical Devices.
I would ask this person to participate to some TOPRA trainings to get clarity on what are the regulatory requirements for devices. But what is important is experience. You should for sure try to learn but you should practice. As you have experience in Medical Device production, you also have some positive skill that can help you. Regulatory affaits foes have a huge scope and design is one if it which can help to define specifications of the product. So do not think that production is really far from regulatory affairs.
@@EasyMedicalDevice Thanks for your reply, I really enjoy your podcasts and as we are in lockdown in Ireland, I am watching all your podcasts as I find them very enjoyable and informative.
If you are a Regulatory Affairs Professional, you really need to listen to this. Samantha Alsbury from TOPRA is providing us with her advice on how to be a great professional. Thanks again to Samantha for her time and for the valuable information she had shared with us.
One of the challenge I have felt in my experience while working in medical devices is also to know about human autonomy. This adds to the complexity because sometimes to understand the device from a design perspective it is necessary to know why design inputs work the way they do. For that a preliminary knowledge of human anatomy is needed. Especially if you have interest towards clinical or medical affairs role.
The solution to this is Team Work. You should not think you are alone. You should ask Marketing or sales service to explain to you. Or if you can meet a surgeon that works with a device could be great. Be curious but don‘t work alone. Autonomy is also the act of collaboration and self-education.
Could you tell me more plz
Hello , kindly show the path as a regulatory affairs job application as a medical device, I am working in medical device company as a sales ...
sharmistha ghosh you may have to start with the Mini-course EU MDR 2017-745 which is free and then you can go to the Green Belt Certification program.
How can I benefit for TOPRA in transition from Medical and Clinical Research Backgrounds to Medical Writer Regulatory Affairs?
HELLO SIR , I am doing m.pharm in dra.. how should i approach to another courses along with these course
which is more demandable regulatory affairs or medical affairs
can a product made up of two 510k cleared medical devices and no biologics or drugs be classified as a combination device?
Hi.. can 10 yr experience cmc regulatory affairs person can understand medical device regulatory?
Hi Dr Mira. Not really an easy move as the regulations are completely different. But this will be easier than to start from scratch with no regulatory background
Whats the salary and how are the growth rate ?
Love to know about this as I have all the background to work but never can get beyond with simple honest work ..
What advice, would you have for a person, who does not have an engineering or life science degree. I have a law degree and want to get into, Regulatory Affairs of Medical Devices, I also 15 years experience of production of Medical Devices.
I would ask this person to participate to some TOPRA trainings to get clarity on what are the regulatory requirements for devices. But what is important is experience. You should for sure try to learn but you should practice. As you have experience in Medical Device production, you also have some positive skill that can help you. Regulatory affaits foes have a huge scope and design is one if it which can help to define specifications of the product. So do not think that production is really far from regulatory affairs.
@@EasyMedicalDevice Thanks for your reply, I really enjoy your podcasts and as we are in lockdown in Ireland, I am watching all your podcasts as I find them very enjoyable and informative.